105th Congress: Democratic Perspectives House Committee on Energy and Commerce Democrats Welcome Page
ADDITIONAL VIEWS
OF
MR. BROWN, MR. MARKEY,
MR. WAXMAN, AND MS. DEGETTE
Our support and the support of many of our colleagues on the Judiciary Committee who previously voted for H.R. 872 is contingent on one very specific understanding: that this legislation not be expanded beyond the form reported by the Commerce Committee.
Even in the legislation as reported, we have some concerns relating to the scope of its protections. While we understand the arguments made in support of this legislation as it relates to the supply of raw materials, this bill also protects the manufacturers of "component parts" of implantable devices. Raw materials, such as silicone or polyethylene, are vastly different subject matter from components, which can be as technically diverse as batteries, tubes, wiring and pacemaker leads. Yet there is little, if any, substantiation in the legislative record for broadening H.R. 872's protections to the manufacturers of such components.
While we supported the bill moving forward, we believe liability protection for manufacturers of component parts should be carefully reviewed before this bill achieves final passage. If the provision remains in the bill, it should be construed as narrowly as possible to avoid unintended consequences of limiting liability of the makers of the manufactured pieces of such devices.
But our primary concerns arise from any potential expansion in the scope and effect of H.R. 872. We would be strongly opposed to changes in which FDA-regulated products are included within the class of biomaterials that receive special protections in this bill. Moreover, we would also oppose any effort to make H.R. 872 a vehicle for broader product liability protections in the House or in the Senate.
On June 23, 1998, we received a letter from Jim Benson, executive vice president of the Health Industry Manufacturers Association (HIMA), assuring us that it is the intention of that organization to oppose any efforts to change the bill as reported or encumber it with other legislative items.
This possibility is not mere speculation. On July 9, 1998, the New York Times reported that Senate Majority Leader Lott had handwritten an amendment into the Senate version of H.R. 872 on behalf of a major medical device manufacturer, Baxter International. Baxter recently lost a $18 million lawsuit to the family of Andrina Hansen, who suffered severe brain damage because of a faulty Baxter intravenous, or IV, connector.
In 1991, Mrs. Hansen underwent surgery for a bleeding ulcer. After successful surgery, the disconnection of a postoperative IV forced air into her brain, causing a stroke. Mrs. Hansen spent four years in a nursing home as a quadriplegic before she died. When her family took legal action, all defendants settled except Baxter Healthcare, a subsidiary of Baxter International and the manufacturer of the faulty IV connector.
According to the court record, Baxter's internal memoranda documented the company's awareness that its IV connector design allowed IV tubing to slip. This defect was also the subject of almost 70 lawsuits over 20 years. Baxter also manufactured a newer, improved connector which prevented fatal incidents like Mrs. Hansen's. But Baxter never warned patients or health providers of these problems.
The proposed Senate amendment would insulate Baxter and similar undeserving manufacturers of component parts of "containers and their related products to be used to collect fluids or tissue from the body or to infuse or to otherwise introduce fluids or tissue into the body" from liability for defective and dangerous products. This would be true even if it was the component, such as Baxter's defective IV connector, and not the entire device which was the cause of injuries or deaths.
In a July 10 letter to Senate Majority Leader Lott, Alan Magazine, president, and Ronald Dollens, chairman-elect of HIMA wrote of their organization's "very serious concerns about expanding [H.R. 872] to medical devices not considered during the four-year long debate on this legislation."
We take them at their word in this commitment, and we accept the assurance of our colleagues on the Commerce Committee that passage of this bill without amendment is their intention. But if that is not the case -- if it is amended adversely on the House floor or becomes a vehicle for unwarranted Senate changes -- then we will not support it and in fact will do all we can to see that it does not become law.
SHERROD BROWN
EDWARD J. MARKEY
HENRY A. WAXMAN
DIANA DEGETTE
105th Congress: Democratic Perspectives
House Committee on Energy and Commerce Democrats Welcome Page